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Clofarabine, Cytarabine, and Idarubicin in Treating Patients With Intermediate-Risk or High-Risk Acute Myeloid Leukemia or High-Risk Myelodysplasia

NCT00838240 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2012-07-20

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine, cytarabine, and idarubicin, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This randomized phase I/II trial is studying the side effects and best dose of clofarabine and to see how well it works when given together with cytarabine and idarubicin in treating patients with intermediate-risk or high-risk acute myeloid leukemia or high-risk myelodysplasia.

Conditions

Interventions

DRUG

clofarabine

Given IV

DRUG

cytarabine

Given IV

DRUG

idarubicin

Given IV

Sponsors & Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Roel Willemze · EORTC (Phase I) - Leiden University Medical Center, NL

  • Dominik Selleslag · EORTC (Phase II) - AZ Sint-Jan, BE

  • Giovanna Meloni · GIMEMA (Phase I & II) - Universita Degli Studi "La Sapienza", IT

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2012-12-31

Countries

  • Belgium
  • Croatia
  • France
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00838240 on ClinicalTrials.gov